Description
FDA has developedthis guidancedocument to assist industry in preparing premarket notification submissions (510(k)s) for dental handpieces intended to prepare dental cavities for restorations, such as fillings, and for cleaning teeth. (21 CFR 872.4200). This guidance supersedes the document entitled, Guidance Document on Dental Handpieces issued July 1995. It updates the references and clarifies the recommendations.
Scope & Applicability
Product Classes
2Subject of the premarket notification guidance for preparing dental cavities and cleaning teeth.
Device category that may be exempt from certain UDI requirements if GMP exempt.
Stakeholders
1Entity responsible for submitting NDINs
Regulatory Context
Attributes
1Determines the information to be submitted based on risks associated with software failure.
Identified Hazards
Hazards
4Risk associated with construction, traffic flow, and shared equipment.; Risk from raw food to RTE food or from insanitary objects; Personnel handling RTE foods touch contaminated surfaces
Excessive radiant power output can result in a thermal hazard
Identified Risk: Thermal injury
Risk management information should identify hazardous situations such as adverse tissue reaction.
Related CFR Sections (4)
- 21CFR872.4200§ 872.4200 Dental handpiece and accessories.
(a) Identification. A dental handpiece and accessories is an AC-powered, water-powered, air-powered, or belt-driven, hand-held device that may include a foot controller for regulation of speed and direction of rotation or a contra-angle attachment for difficult to reach areas intended to prepare denRead full regulation →
- 21CFR801.109§ 801.109 Prescription devices.
A device which, because of any potentiality for harmful effect, or the method of its use, or the collateral measures necessary to its use is not safe except under the supervision of a practitioner licensed by law to direct the use of such device, and hence for which “adequate directions for use” canRead full regulation →
- 21CFR807.87§ 807.87 Information required in a premarket notification submission.
Each premarket notification submission shall contain the following information:Read full regulation →
- 21CFR807.81§ 807.81 When a premarket notification submission is required.
(a) Except as provided in paragraph (b) of this section, each person who is required to register his establishment pursuant to § 807.20 must submit a premarket notification submission to the Food and Drug Administration at least 90 days before he proposes to begin the introduction or delivery for inRead full regulation →
Related Warning Letters (10)
- 2025-09-16
Investigational Device Exemptions (IDE)/Premarket Approval Application (PMA) Adulterated Device
SeniorLife Technologies, Inc.
- 2025-08-05
CGMP/QSR/Medical Devices/Adulterated
Mectronic Medicale S.R.L.
- 2025-07-15
Investigational Device Exemptions (IDE)/Premarket Approval Application (PMA)
WHOOP, Inc.
- 2025-05-27
Investigational Device Exemptions (IDE)/Premarket Approval Application (PMA) Adulterated Device
DRG Instruments GmbH
- 2025-03-25
Investigational Device Exemptions (IDE)/Premarket Approval Application (PMA) Adulterated Device
Rex Implants Inc.
- 2024-09-10
CGMP/QSR/Medical Devices/Adulterated
Optikem International, Inc.
- 2024-08-28
Investigational Device Exemptions (IDE)/Premarket Approval Application (PMA) Adulterated Device
Shenzhen Moyeah Intelligent Life Technology Co.
- 2024-08-28
Investigational Device Exemptions (IDE)/Premarket Approval Application (PMA) Adulterated Device
Adventure Innovations LLC
- 2024-08-28
Investigational Device Exemptions (IDE)/Premarket Approval Application (PMA) Adulterated Device
Natures Pillows, Inc. and Top Dog Direct, LLC
- 2024-08-13
Investigational Device Exemptions (IDE)/Premarket Approval Application (PMA) Adulterated Device
Baylab USA, LLC
See Also (8)
- Air Powered Dental Handpieces and Air Motors - Performance Criteria for Safety and Performance Based Pathway: Guidance for Industry and Food and Drug Administration Staff (Status: Final)
- Surgical Staplers and Staples for Internal Use - Labeling Recommendations: Guidance for Industry and Food and Drug Administration Staff (Status: Final)
- 510(k) Checklist for Sterile Lubricating Jelly Used With Transurethral Surgical Instruments (Status: Final)
- CPG Sec. 370.100 Cytotoxic Testing for Allergic Diseases (Status: Final)
- CPG Sec. 390.425 Records and Reports; Applicability - 21 CFR 1002.1 (Status: Final)
- Hysteroscopic and Laparoscopic Insufflators: Submission Guidance for a 510(k) (Status: Final)
- Addendum to: Guidance on Premarket Notification [510(k)] Submissions for Sterilizers Intended for Use in Health Care Facilities (Status: Final)
- Checklist of Information Usually Submitted in an Investigational Device Exemptions (IDE) Application for Refractive Surgery Lasers [excimer] (Status: Final)